Prolonged Nightly Fasting in Fibromyalgia

Sponsor

Arizona State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05581849

Collaborator

(none)

Enrollment

Arms

10.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week prolonged nightly fasting (PNF) intervention protocol in 20 adults with fibromyalgia.

Aim 1: Evaluate feasibility and acceptability of the PNF intervention among participants with fibromyalgia.

Aim 2: Evaluate preliminary efficacy of PNF on pain severity and sensitivity, mood, sleep and inflammation.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Behavioral: Prolonged Nightly Fasting Behavioral: Health Education Control	N/A

Detailed Description

Fibromyalgia is characterized by chronic widespread pain, sleep disturbance, fatigue, negative mood, and cognitive dysfunction. It is estimated about 4 million individuals in the U.S. are affected by fibromyalgia, which results in high disability, lost productivity, and poor quality of life. Various medications have been tested, but findings suggest only small therapeutic effects with high side effects. First line evidence-based psychosocial interventions, such as cognitive behavioral therapy, also yield only small to moderate treatment effects and they require specialized personnel. Thus, there is a dire need to develop a novel approach to manage fibromyalgia symptoms with a high safety profile, are affordable, and are easily implemented by participants without extensive guidance and support from specialized personnel.

Prolonged nightly fasting (PNF) which is a type of time-restricted eating with no or minimal caloric intake for periods of time as few as 12 hours has been shown to promote various health benefits. PNF has also been demonstrated to be highly acceptable and adherable for adults with various clinical condition. Although some dietary patterns have been explored for their impact on pain, the effects of PNF on pain-related outcomes (e.g., pain severity, pain sensitivity), mood, sleep, and inflammation among individuals with fibromyalgia have not been examined. The present randomized-controlled pilot trial will test the feasibility, acceptability, and preliminary efficacy of an 8-week PNF intervention protocol in 20 adults with fibromyalgia.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prolonged Nightly Fasting in Individuals With Fibromyalgia: A Pilot Study

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prolonged Nightly Fasting (PNF) Participants will engage in the PNF (14+ hours a night of fasting and no calorie containing food or beverages) for 8 weeks.	Behavioral: Prolonged Nightly Fasting Participants will engage in 14+ hours a night of fasting and no calorie containing food or beverages for 8 weeks. Participants will be allotted one "cheat day" per week, during which they will not need to fast (or track their times)- the day may change weekly and will be based on participant preference. Study staff and study participants will engage in a weekly coaching call (via phone; 5-10 minutes). Weekly coaching calls will last through the duration of the 8-week intervention. Other Names: Intermittent Fasting
Active Comparator: Health Education Control (HEC) Participants in HEC group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks.	Behavioral: Health Education Control Participants in this group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks. Participants will be asked to review the video at their convenience, prior to their weekly coaching call (5-10 minutes) with the study staff. Weekly topics will be as follows: Week 1: Sleep hygiene, Week 2: Sun safety, Week 3: Home safety, Week 4: Driving safety, Week 5: Hydration, Week 6: Dental health, Week 7: Working environment, Week 8: Communication.

Arm

Intervention/Treatment

Experimental: Prolonged Nightly Fasting (PNF)

Participants will engage in the PNF (14+ hours a night of fasting and no calorie containing food or beverages) for 8 weeks.

Behavioral: Prolonged Nightly Fasting

Participants will engage in 14+ hours a night of fasting and no calorie containing food or beverages for 8 weeks. Participants will be allotted one "cheat day" per week, during which they will not need to fast (or track their times)- the day may change weekly and will be based on participant preference. Study staff and study participants will engage in a weekly coaching call (via phone; 5-10 minutes). Weekly coaching calls will last through the duration of the 8-week intervention.

Other Names:

Intermittent Fasting

Active Comparator: Health Education Control (HEC)

Participants in HEC group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks.

Behavioral: Health Education Control

Participants in this group will receive weekly 15-minute videos (once weekly) focused on non-diet/non-fasting health educational content for 8 weeks. Participants will be asked to review the video at their convenience, prior to their weekly coaching call (5-10 minutes) with the study staff. Weekly topics will be as follows: Week 1: Sleep hygiene, Week 2: Sun safety, Week 3: Home safety, Week 4: Driving safety, Week 5: Hydration, Week 6: Dental health, Week 7: Working environment, Week 8: Communication.

Outcome Measures

Primary Outcome Measures

Feasibility--drop-out rate [At 8 weeks post-treatment]
Feasibility--adherence to intervention [At 8 weeks post-treatment]
The number of days prolonged nightly fasting was completed divided by the total number of treatment days
Acceptability of the intervention [At 8 weeks post-treatment]
It will be measured by the Global Satisfaction subscale in an adapted version of the Treatment Satisfaction Questionnaire for Medication. The scores are calculated for each of the subscales, which range from 0 to 100, with higher scores indicating higher patient satisfaction with the intervention.

Secondary Outcome Measures

Fatigue [Baseline and 8 weeks post-treatment]
Total score of Fatigue Severity Scale
Fibromyalgia symtpoms [Baseline and 8 weeks post-treatment]
Total score from Revised Fibromyalgia Impact Questionnaire (FIQR)
Cognitive Functioning [Baseline and 8 weeks post-treatment]
Total score from Montreal Cognitive Assessment (MoCA)
Pain Severity [Baseline and 8 weeks post-treatment]
Average of 4 items from the Brief Pain Inventory; each rated on a 0 (no pain) to 10 (pain as bad as you can imagine); ratings are made of pain right now, typical pain, worst pain, and least pain during the past week.
Central Sensitization Index [Baseline and 8 weeks post-treatment]
Index of thermal temporal summation, mechanical temporal summation, conditioned pain modulation, and aftersensations
Pain Interference [Baseline and 8 weeks post-treatment]
Average of 7 items from the Brief Pain Inventory; assessing the extent to which participant experienced that pain interfered with their (1) general activity, (2) mood; (3) walking ability; (4) normal walk; (5) relations with other people, (6) sleep, and (7) enjoyment of life
Inflammatory levels [Baseline and 8 weeks post-treatment]
IL-1β, IL-6, and TNF-α and C-Reactive Protein (CRP) levels
Total Sleep Time (TST) [Baseline and 8 weeks post-treatment]
TST is defined as the total number of minutes asleep between the time a participant goes to bed at night and the time a participant gets out of bed in the morning. TST will be derived from ambulatory EEG sleep monitoring.
Depressive symptoms [Baseline and 8 weeks post-treatment]
T-score from PROMIS Emotional Distress-Depression-Short Form

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

age between 18 and 65
female
able to speak, write, and read English
classified as having fibromyalgia based upon criteria established by the most up-to-date 2016 American College of Rheumatology (ACR) Criteria for Fibromyalgia
has a smartphone.

Exclusion Criteria:

history of eating disorders assessed by MINI Neuropsychiatric Interview
self-report of chronic malignant pain (e.g., cancer, HIV) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus)
current use of melatonin or an immunosuppressant medication (e.g., steroids)
currently pregnant, trying to get pregnant, or breastfeeding
plans to relocate within the next 6 months
has diabetes mellitus
currently trying to lose weight
currently routinely fasting more than 12 hours a night
works night shifts